NCT00224289

Brief Summary

Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it is plausible that the age of a patient using the medication may affect its efficacy and time of onset. We are going to study the effectiveness of Latanoprost in people of different ages, to see if it changes based on the age of the patient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

December 10, 2012

Completed
Last Updated

December 10, 2012

Status Verified

November 1, 2012

Enrollment Period

4.1 years

First QC Date

September 16, 2005

Results QC Date

November 9, 2012

Last Update Submit

November 9, 2012

Conditions

Keywords

LatanoprostGlaucomaIntraocular pressure

Outcome Measures

Primary Outcomes (2)

  • Pre-Treatment IOP (Intraocular Pressure)

    Subjects applied topical latanoprost at bedtime for 8 weeks

    At baseline (before treatment)

  • Post-Treatment IOP (Intraocular Pressure)

    Subjects applied topical latanoprost at bedtime for 8 weeks

    8 Weeks

Study Arms (1)

1

OTHER

All participants will be taking Latanoprost; This study compares efficacy within age groups.

Drug: Latanoprost 0.005%

Interventions

Latanoprost 0.005% ophthalmic solution QHS 8 weeks

Also known as: Xalatan
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of open angle glaucoma,
  • pseudoexfoliation glaucoma, pigmentary glaucoma or ocular hypertension in one or both eyes;
  • IOP above their target pressure as determined by a glaucoma specialist;
  • willingness to participate in the study.

You may not qualify if:

  • hypersensitivity to any of the components of the treatment medication;
  • previous use of topical prostaglandins;
  • documented ocular infection or intraocular inflammation within the past year;
  • previous filtering surgery or complicated cataract surgery;
  • active corneal disease;
  • presence of cystoid macular edema;
  • laser trabeculoplasty or any other ocular laser procedure within the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Eye Center

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Bruce Shields, MD
Organization
Principal Investigator

Study Officials

  • Bruce Shields, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

December 10, 2012

Results First Posted

December 10, 2012

Record last verified: 2012-11

Locations